ZIAGEN® Post-marketing Surveillance

ViiV Healthcare

Status: Completed

Conditions: Infection, Human Immunodeficiency Virus I

Treatments: Drug: ZIAGEN®

Study type: Observational

Funder types: Industry

Identifiers

NCT01205243

114382

Details and patient eligibility

About

An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information.

Full description

This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of KFDA for market authorization.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Enrollment: 671 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All subjects must satisfy the following criteria.

• Subject who is treated in combination with other antiretroviral agents for the treatment of HIV infection.
• Subject who is considered to follow this post marketing surveillance protocol by the investigator.
• Subject who is treated with ZIAGEN® according to the prescribing information. As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe ZIAGEN® according to the prescribing information which approved in Korea.
• Subjects with hypersensitivity to ZIAGEN® or ingredients
• Subjects with moderate or severe hepatic impairment
• Subject with end-stage renal disease

Trial design

671 participants in 1 patient group

ZIAGEN®

Description:

Patients administrated ZIAGEN® at the site

Treatment:

Drug: ZIAGEN®